Palonosetron 0.25 mg/5 ml (as Palonosetron hydrochloride)
Injection solution
Prevent nausea and vomiting caused by cancer chemotherapy
Prevent nausea and vomiting after surgery
Adults
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Palono-BFS should be injected over 30 seconds.
The efficacy of Palono-BFS in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Elderly people
No dose adjustment is necessary for the elderly.
Paediatric population
Children and Adolescents (aged 1 month to 17 years):
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
The safety and efficacy of Palono-BFS in children aged less than 1 month have not been established. No data are available. There are limited data on the use of Palono-BFS in the prevention of nausea and vomiting in children under 2 years of age.
Hepatic impairment
No dose adjustment is necessary for patients with impaired hepatic function.
Renal impairment
No dose adjustment is necessary for patients with impaired renal function.
No data are available for patients with end stage renal disease undergoing haemodialysis.